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WO2000035673A1 - Multilayered film and container - Google Patents

Multilayered film and container Download PDF

Info

Publication number
WO2000035673A1
WO2000035673A1 PCT/JP1999/006932 JP9906932W WO0035673A1 WO 2000035673 A1 WO2000035673 A1 WO 2000035673A1 JP 9906932 W JP9906932 W JP 9906932W WO 0035673 A1 WO0035673 A1 WO 0035673A1
Authority
WO
WIPO (PCT)
Prior art keywords
layer
density
multilayer film
ethylene
mixed resin
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Ceased
Application number
PCT/JP1999/006932
Other languages
French (fr)
Japanese (ja)
Inventor
Tamotsu Kataoka
Takayuki Denpou
Motoaki Suzaki
Tatsuya Tanaka
Shigetoshi Kashiyama
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Otsuka Pharmaceutical Co Ltd
Otsuka Pharmaceutical Factory Inc
Original Assignee
Otsuka Pharmaceutical Co Ltd
Otsuka Pharmaceutical Factory Inc
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Otsuka Pharmaceutical Co Ltd, Otsuka Pharmaceutical Factory Inc filed Critical Otsuka Pharmaceutical Co Ltd
Priority to EP99959741A priority Critical patent/EP1153742B1/en
Priority to US09/857,898 priority patent/US6905744B1/en
Priority to DE69930767T priority patent/DE69930767T2/en
Priority to CA002353497A priority patent/CA2353497C/en
Priority to AU16833/00A priority patent/AU761628B2/en
Publication of WO2000035673A1 publication Critical patent/WO2000035673A1/en
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

Links

Classifications

    • BPERFORMING OPERATIONS; TRANSPORTING
    • B32LAYERED PRODUCTS
    • B32BLAYERED PRODUCTS, i.e. PRODUCTS BUILT-UP OF STRATA OF FLAT OR NON-FLAT, e.g. CELLULAR OR HONEYCOMB, FORM
    • B32B27/00Layered products comprising a layer of synthetic resin
    • B32B27/32Layered products comprising a layer of synthetic resin comprising polyolefins
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61JCONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/05Containers specially adapted for medical or pharmaceutical purposes for collecting, storing or administering blood, plasma or medical fluids ; Infusion or perfusion containers
    • A61J1/10Bag-type containers
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B32LAYERED PRODUCTS
    • B32BLAYERED PRODUCTS, i.e. PRODUCTS BUILT-UP OF STRATA OF FLAT OR NON-FLAT, e.g. CELLULAR OR HONEYCOMB, FORM
    • B32B27/00Layered products comprising a layer of synthetic resin
    • B32B27/06Layered products comprising a layer of synthetic resin as the main or only constituent of a layer, which is next to another layer of the same or of a different material
    • B32B27/08Layered products comprising a layer of synthetic resin as the main or only constituent of a layer, which is next to another layer of the same or of a different material of synthetic resin
    • CCHEMISTRY; METALLURGY
    • C08ORGANIC MACROMOLECULAR COMPOUNDS; THEIR PREPARATION OR CHEMICAL WORKING-UP; COMPOSITIONS BASED THEREON
    • C08LCOMPOSITIONS OF MACROMOLECULAR COMPOUNDS
    • C08L23/00Compositions of homopolymers or copolymers of unsaturated aliphatic hydrocarbons having only one carbon-to-carbon double bond; Compositions of derivatives of such polymers
    • C08L23/02Compositions of homopolymers or copolymers of unsaturated aliphatic hydrocarbons having only one carbon-to-carbon double bond; Compositions of derivatives of such polymers not modified by chemical after-treatment
    • C08L23/04Homopolymers or copolymers of ethene
    • C08L23/08Copolymers of ethene
    • C08L23/0807Copolymers of ethene with unsaturated hydrocarbons only containing four or more carbon atoms
    • C08L23/0815Copolymers of ethene with unsaturated hydrocarbons only containing four or more carbon atoms with aliphatic 1-olefins containing one carbon-to-carbon double bond
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2207/00Methods of manufacture, assembly or production
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B29WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29CSHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
    • B29C65/00Joining or sealing of preformed parts, e.g. welding of plastics materials; Apparatus therefor
    • B29C65/02Joining or sealing of preformed parts, e.g. welding of plastics materials; Apparatus therefor by heating, with or without pressure
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B29WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29CSHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
    • B29C66/00General aspects of processes or apparatus for joining preformed parts
    • B29C66/01General aspects dealing with the joint area or with the area to be joined
    • B29C66/02Preparation of the material, in the area to be joined, prior to joining or welding
    • B29C66/024Thermal pre-treatments
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B29WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29CSHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
    • B29C66/00General aspects of processes or apparatus for joining preformed parts
    • B29C66/01General aspects dealing with the joint area or with the area to be joined
    • B29C66/05Particular design of joint configurations
    • B29C66/10Particular design of joint configurations particular design of the joint cross-sections
    • B29C66/11Joint cross-sections comprising a single joint-segment, i.e. one of the parts to be joined comprising a single joint-segment in the joint cross-section
    • B29C66/112Single lapped joints
    • B29C66/1122Single lap to lap joints, i.e. overlap joints
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B29WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29CSHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
    • B29C66/00General aspects of processes or apparatus for joining preformed parts
    • B29C66/40General aspects of joining substantially flat articles, e.g. plates, sheets or web-like materials; Making flat seams in tubular or hollow articles; Joining single elements to substantially flat surfaces
    • B29C66/41Joining substantially flat articles ; Making flat seams in tubular or hollow articles
    • B29C66/43Joining a relatively small portion of the surface of said articles
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B29WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29CSHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
    • B29C66/00General aspects of processes or apparatus for joining preformed parts
    • B29C66/50General aspects of joining tubular articles; General aspects of joining long products, i.e. bars or profiled elements; General aspects of joining single elements to tubular articles, hollow articles or bars; General aspects of joining several hollow-preforms to form hollow or tubular articles
    • B29C66/51Joining tubular articles, profiled elements or bars; Joining single elements to tubular articles, hollow articles or bars; Joining several hollow-preforms to form hollow or tubular articles
    • B29C66/53Joining single elements to tubular articles, hollow articles or bars
    • B29C66/532Joining single elements to the wall of tubular articles, hollow articles or bars
    • B29C66/5326Joining single elements to the wall of tubular articles, hollow articles or bars said single elements being substantially flat
    • B29C66/53261Enclosing tubular articles between substantially flat elements
    • B29C66/53262Enclosing spouts between the walls of bags, e.g. of medical bags
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B29WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29CSHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
    • B29C66/00General aspects of processes or apparatus for joining preformed parts
    • B29C66/70General aspects of processes or apparatus for joining preformed parts characterised by the composition, physical properties or the structure of the material of the parts to be joined; Joining with non-plastics material
    • B29C66/71General aspects of processes or apparatus for joining preformed parts characterised by the composition, physical properties or the structure of the material of the parts to be joined; Joining with non-plastics material characterised by the composition of the plastics material of the parts to be joined
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B29WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29CSHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
    • B29C66/00General aspects of processes or apparatus for joining preformed parts
    • B29C66/70General aspects of processes or apparatus for joining preformed parts characterised by the composition, physical properties or the structure of the material of the parts to be joined; Joining with non-plastics material
    • B29C66/72General aspects of processes or apparatus for joining preformed parts characterised by the composition, physical properties or the structure of the material of the parts to be joined; Joining with non-plastics material characterised by the structure of the material of the parts to be joined
    • B29C66/723General aspects of processes or apparatus for joining preformed parts characterised by the composition, physical properties or the structure of the material of the parts to be joined; Joining with non-plastics material characterised by the structure of the material of the parts to be joined being multi-layered
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B29WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29CSHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
    • B29C66/00General aspects of processes or apparatus for joining preformed parts
    • B29C66/70General aspects of processes or apparatus for joining preformed parts characterised by the composition, physical properties or the structure of the material of the parts to be joined; Joining with non-plastics material
    • B29C66/73General aspects of processes or apparatus for joining preformed parts characterised by the composition, physical properties or the structure of the material of the parts to be joined; Joining with non-plastics material characterised by the intensive physical properties of the material of the parts to be joined, by the optical properties of the material of the parts to be joined, by the extensive physical properties of the parts to be joined, by the state of the material of the parts to be joined or by the material of the parts to be joined being a thermoplastic or a thermoset
    • B29C66/731General aspects of processes or apparatus for joining preformed parts characterised by the composition, physical properties or the structure of the material of the parts to be joined; Joining with non-plastics material characterised by the intensive physical properties of the material of the parts to be joined, by the optical properties of the material of the parts to be joined, by the extensive physical properties of the parts to be joined, by the state of the material of the parts to be joined or by the material of the parts to be joined being a thermoplastic or a thermoset characterised by the intensive physical properties of the material of the parts to be joined
    • B29C66/7313Density
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B29WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29CSHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
    • B29C66/00General aspects of processes or apparatus for joining preformed parts
    • B29C66/90Measuring or controlling the joining process
    • B29C66/91Measuring or controlling the joining process by measuring or controlling the temperature, the heat or the thermal flux
    • B29C66/914Measuring or controlling the joining process by measuring or controlling the temperature, the heat or the thermal flux by controlling or regulating the temperature, the heat or the thermal flux
    • B29C66/9141Measuring or controlling the joining process by measuring or controlling the temperature, the heat or the thermal flux by controlling or regulating the temperature, the heat or the thermal flux by controlling or regulating the temperature
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B29WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29CSHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
    • B29C66/00General aspects of processes or apparatus for joining preformed parts
    • B29C66/90Measuring or controlling the joining process
    • B29C66/91Measuring or controlling the joining process by measuring or controlling the temperature, the heat or the thermal flux
    • B29C66/914Measuring or controlling the joining process by measuring or controlling the temperature, the heat or the thermal flux by controlling or regulating the temperature, the heat or the thermal flux
    • B29C66/9161Measuring or controlling the joining process by measuring or controlling the temperature, the heat or the thermal flux by controlling or regulating the temperature, the heat or the thermal flux by controlling or regulating the heat or the thermal flux, i.e. the heat flux
    • B29C66/91641Measuring or controlling the joining process by measuring or controlling the temperature, the heat or the thermal flux by controlling or regulating the temperature, the heat or the thermal flux by controlling or regulating the heat or the thermal flux, i.e. the heat flux the heat or the thermal flux being non-constant over time
    • B29C66/91643Measuring or controlling the joining process by measuring or controlling the temperature, the heat or the thermal flux by controlling or regulating the temperature, the heat or the thermal flux by controlling or regulating the heat or the thermal flux, i.e. the heat flux the heat or the thermal flux being non-constant over time following a heat-time profile
    • B29C66/91645Measuring or controlling the joining process by measuring or controlling the temperature, the heat or the thermal flux by controlling or regulating the temperature, the heat or the thermal flux by controlling or regulating the heat or the thermal flux, i.e. the heat flux the heat or the thermal flux being non-constant over time following a heat-time profile by steps
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B29WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29CSHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
    • B29C66/00General aspects of processes or apparatus for joining preformed parts
    • B29C66/90Measuring or controlling the joining process
    • B29C66/91Measuring or controlling the joining process by measuring or controlling the temperature, the heat or the thermal flux
    • B29C66/919Measuring or controlling the joining process by measuring or controlling the temperature, the heat or the thermal flux characterised by specific temperature, heat or thermal flux values or ranges
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B29WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29KINDEXING SCHEME ASSOCIATED WITH SUBCLASSES B29B, B29C OR B29D, RELATING TO MOULDING MATERIALS OR TO MATERIALS FOR MOULDS, REINFORCEMENTS, FILLERS OR PREFORMED PARTS, e.g. INSERTS
    • B29K2023/00Use of polyalkenes or derivatives thereof as moulding material
    • B29K2023/04Polymers of ethylene
    • B29K2023/06PE, i.e. polyethylene
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B29WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29LINDEXING SCHEME ASSOCIATED WITH SUBCLASS B29C, RELATING TO PARTICULAR ARTICLES
    • B29L2031/00Other particular articles
    • B29L2031/712Containers; Packaging elements or accessories, Packages
    • B29L2031/7148Blood bags, medical bags
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B32LAYERED PRODUCTS
    • B32BLAYERED PRODUCTS, i.e. PRODUCTS BUILT-UP OF STRATA OF FLAT OR NON-FLAT, e.g. CELLULAR OR HONEYCOMB, FORM
    • B32B2309/00Parameters for the laminating or treatment process; Apparatus details
    • B32B2309/08Dimensions, e.g. volume
    • B32B2309/10Dimensions, e.g. volume linear, e.g. length, distance, width
    • B32B2309/105Thickness
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B32LAYERED PRODUCTS
    • B32BLAYERED PRODUCTS, i.e. PRODUCTS BUILT-UP OF STRATA OF FLAT OR NON-FLAT, e.g. CELLULAR OR HONEYCOMB, FORM
    • B32B2323/00Polyalkenes
    • B32B2323/04Polyethylene
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B32LAYERED PRODUCTS
    • B32BLAYERED PRODUCTS, i.e. PRODUCTS BUILT-UP OF STRATA OF FLAT OR NON-FLAT, e.g. CELLULAR OR HONEYCOMB, FORM
    • B32B2323/00Polyalkenes
    • B32B2323/04Polyethylene
    • B32B2323/043HDPE, i.e. high density polyethylene
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B32LAYERED PRODUCTS
    • B32BLAYERED PRODUCTS, i.e. PRODUCTS BUILT-UP OF STRATA OF FLAT OR NON-FLAT, e.g. CELLULAR OR HONEYCOMB, FORM
    • B32B2323/00Polyalkenes
    • B32B2323/10Polypropylene
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B32LAYERED PRODUCTS
    • B32BLAYERED PRODUCTS, i.e. PRODUCTS BUILT-UP OF STRATA OF FLAT OR NON-FLAT, e.g. CELLULAR OR HONEYCOMB, FORM
    • B32B2439/00Containers; Receptacles
    • B32B2439/80Medical packaging
    • CCHEMISTRY; METALLURGY
    • C08ORGANIC MACROMOLECULAR COMPOUNDS; THEIR PREPARATION OR CHEMICAL WORKING-UP; COMPOSITIONS BASED THEREON
    • C08LCOMPOSITIONS OF MACROMOLECULAR COMPOUNDS
    • C08L23/00Compositions of homopolymers or copolymers of unsaturated aliphatic hydrocarbons having only one carbon-to-carbon double bond; Compositions of derivatives of such polymers
    • C08L23/02Compositions of homopolymers or copolymers of unsaturated aliphatic hydrocarbons having only one carbon-to-carbon double bond; Compositions of derivatives of such polymers not modified by chemical after-treatment
    • C08L23/04Homopolymers or copolymers of ethene
    • C08L23/06Polyethene
    • CCHEMISTRY; METALLURGY
    • C08ORGANIC MACROMOLECULAR COMPOUNDS; THEIR PREPARATION OR CHEMICAL WORKING-UP; COMPOSITIONS BASED THEREON
    • C08LCOMPOSITIONS OF MACROMOLECULAR COMPOUNDS
    • C08L23/00Compositions of homopolymers or copolymers of unsaturated aliphatic hydrocarbons having only one carbon-to-carbon double bond; Compositions of derivatives of such polymers
    • C08L23/02Compositions of homopolymers or copolymers of unsaturated aliphatic hydrocarbons having only one carbon-to-carbon double bond; Compositions of derivatives of such polymers not modified by chemical after-treatment
    • C08L23/10Homopolymers or copolymers of propene
    • YGENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10TECHNICAL SUBJECTS COVERED BY FORMER USPC
    • Y10TTECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION
    • Y10T428/00Stock material or miscellaneous articles
    • Y10T428/13Hollow or container type article [e.g., tube, vase, etc.]
    • Y10T428/1352Polymer or resin containing [i.e., natural or synthetic]
    • YGENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10TECHNICAL SUBJECTS COVERED BY FORMER USPC
    • Y10TTECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION
    • Y10T428/00Stock material or miscellaneous articles
    • Y10T428/13Hollow or container type article [e.g., tube, vase, etc.]
    • Y10T428/1352Polymer or resin containing [i.e., natural or synthetic]
    • Y10T428/139Open-ended, self-supporting conduit, cylinder, or tube-type article
    • Y10T428/1393Multilayer [continuous layer]
    • YGENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10TECHNICAL SUBJECTS COVERED BY FORMER USPC
    • Y10TTECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION
    • Y10T428/00Stock material or miscellaneous articles
    • Y10T428/24Structurally defined web or sheet [e.g., overall dimension, etc.]
    • Y10T428/24942Structurally defined web or sheet [e.g., overall dimension, etc.] including components having same physical characteristic in differing degree
    • Y10T428/24992Density or compression of components
    • YGENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10TECHNICAL SUBJECTS COVERED BY FORMER USPC
    • Y10TTECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION
    • Y10T428/00Stock material or miscellaneous articles
    • Y10T428/27Web or sheet containing structurally defined element or component, the element or component having a specified weight per unit area [e.g., gms/sq cm, lbs/sq ft, etc.]
    • YGENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
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    • Y10T428/31504Composite [nonstructural laminate]
    • Y10T428/31855Of addition polymer from unsaturated monomers
    • Y10T428/31909Next to second addition polymer from unsaturated monomers
    • YGENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
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    • Y10T428/00Stock material or miscellaneous articles
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    • Y10T428/31855Of addition polymer from unsaturated monomers
    • Y10T428/31909Next to second addition polymer from unsaturated monomers
    • Y10T428/31913Monoolefin polymer
    • YGENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10TECHNICAL SUBJECTS COVERED BY FORMER USPC
    • Y10TTECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION
    • Y10T428/00Stock material or miscellaneous articles
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    • Y10T428/31855Of addition polymer from unsaturated monomers
    • Y10T428/31938Polymer of monoethylenically unsaturated hydrocarbon
    • YGENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10TECHNICAL SUBJECTS COVERED BY FORMER USPC
    • Y10TTECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION
    • Y10T428/00Stock material or miscellaneous articles
    • Y10T428/31504Composite [nonstructural laminate]
    • Y10T428/31942Of aldehyde or ketone condensation product
    • Y10T428/31946Next to second aldehyde or ketone condensation product

Definitions

  • the present invention relates to a multilayer film and a container formed using the same, and more particularly, to a multilayer film and a container used in the medical field, particularly as a material for containing a chemical solution, blood, and the like.
  • multilayer film As a material.
  • conventional multi-layer medical containers include those made of the following polyethylene resins.
  • a three-layer bag made of linear low-density polyethylene, wherein the density of the inner and outer layers is 0.920 g / cm 3 or more, and the density of the middle layer is less than 0.920 g / cm 3 .
  • the conventional medical multilayer container has one of the following disadvantages. ing.
  • the heat resistance is not sufficient because the inner and outer layers of the film are made of low-density polyethylene resin, and the seal strength and drop strength are reduced by sterilization under high-temperature conditions such as high-pressure steam sterilization and hot water sterilization. descend.
  • an object of the present invention is to provide a multilayer film which is excellent in heat resistance, blocking resistance, strength, sealability, transparency and flexibility, and which can prevent generation of pinholes in a bent portion during heat sealing. It is to provide a container. Disclosure of the invention
  • the inventors of the present invention have conducted intensive research to solve the above-mentioned problems, and have formed a three-layer structure of the intermediate layer, a resin or mixed resin disposed in each layer, and a layer of the entire multilayer film.
  • a completely new resin composition that can improve the heat resistance without impairing the basic properties such as transparency and flexibility, and the combination of the arrangement of the resin were found. This led to the completion of the present invention.
  • the present invention relates to a multilayer film comprising five layers
  • Layer is the (A) Density 0 ⁇ 930 ⁇ 0. 950 g / cm 3 of ethylene flying one year old Refuin co polymer, the second layer (B) Density 0. 9 10 ⁇ 0. 930 g / cm 3 Ethylene-Hyperolefin copolymer 30-60% by weight, Density 0.860-0.900 g / cm 3 Ethylene olefin elastomer 35-65% by weight and Density 0.955- 0. 970 g / cm 3 in the mixed resins consisting of high density polyethylene 1-10 wt%, or, (C) density 0. 900 ⁇ 0.
  • a mixed resin consisting of 860-0.900 gZcm 3 of ethylene '' one-year-old refin-based elastomer 40-60% by weight and density 0.955-5.970 g / cm 3 High-density polyethylene 2-8% by weight
  • the third layer is the above-mentioned (A) the ethylene'polyolefin copolymer, or (D) the polypropylene having a density of 0.900 to 0.930 g / cm 3 40 to 60% by weight and the density of 0.860 to 0. of 900 g / cm 3 ethylene-Fei one Orefu
  • a mixed resin comprising 40 to 60% by weight of an epoxy-based elastomer, and the fourth layer is the mixed resin of the above (C).
  • the multilayer film of the present invention it is possible to sufficiently prevent the occurrence of binholes, for example, when manufacturing the medical container (infusion bag) 10 described above.
  • the heat welding of the port 20 can be performed at a relatively high temperature, and the film does not extend too much at the bent portion 24, it is possible to reliably prevent the occurrence of a binhole at the bent portion 24.
  • FIG. 1 is a front view showing an embodiment of the container of the present invention.
  • FIG. 2 is a partial cross-sectional view taken along line AA of FIG.
  • the second layer is the mixed resin of the above (C)
  • the third layer is the ethylene 'olefin copolymer of the above (A). What This is preferable from the viewpoint of reducing manufacturing costs while maintaining heat resistance.
  • the polypropylene used for the mixed resin (C) or (D) has a melt flow rate (MFR) of 1 to 40 g / l 0 min (230 ° C), A melting point of 140 to 170 ° C. is preferred from the viewpoint of compatibility with other resins.
  • the proportion of the thickness of each layer in the multilayer film of the present invention is 5 to 15% for the first layer, 25 to 45% for the second layer, 2 to 15% for the third layer, It is preferable that the fourth layer has a range of 25 to 45% and the fifth layer has a range of 7 to 20% .
  • the first layer has a range of 5 to 10%
  • the second layer has a range of 30 to 45%
  • the third layer has a range of 2 to 10%.
  • the fourth layer is 30-45% and the fifth layer? More preferably, it is in the range of 15%.
  • the container of the present invention is characterized in that any one of the above-mentioned multilayer films is used, and the first layer of the multilayer film is formed as an outer layer and the fifth layer is formed as an inner layer.
  • the container of the present invention is formed by using the multilayer film of the present invention, it has high heat resistance, good blocking resistance, strength, sealing property, flexibility and transparency, and sufficient generation of bin holes. Can be prevented.
  • the physical properties specified in the present invention are all based on the rules of the American Society for Testing and Materials (ASTM), and the density is ASTM D1505 and the melt flow rate (MFR) is ASTM D1238. The melting point is measured according to ASTM D2117.
  • olefins in the title copolymer or elastomer examples include propylene, 1-butene, 1-pentene, 1-hexene, 4-methyl-1-1-pentene, 1-heptene, 1-octene, 1-octene —Oneolefin having 3 to 12 carbon atoms, such as —nonene, 1-decene, 1-decene, and 1-dodecene.
  • those having a single branched chain produced by a medium-to-low pressure method are particularly preferably used.
  • the high-density polyethylene described above may be a homopolymer of ethylene or a copolymer with ethylene glycol.
  • the monorefin include the above-mentioned monorefin having 3 to 12 carbon atoms. Although the content ratio of the monoolefin is not particularly limited, it is usually set in the range of 0.1 to 5 mol%.
  • the high-density polyethylene used in the present invention has a density in the range of 0.955 to 0.970 g / cm 3 , and among them, one having an MFR of 1 to 30 g / 10 minutes (190 ° C) It is suitable.
  • the title polypropylene may be a homopolymer of propylene or a copolymer containing a small amount of ethylene or ⁇ -olefin.
  • the one-year-old refin for example, the one-year-old fin having the carbon number of about 4 to 12 among the above-mentioned one-year-old fins such as 1-butene is exemplified.
  • the content ratio of Hiichi Sai Refin is usually set within the range of 10% by weight or less.
  • the polypropylene used in the present invention has a density in the range of 0.900 to 0.930 g / cm 3 , especially having an MFR of 1 to 40 g / 10 minutes (230 ° C) and a melting point of 140 to Isotactic polypropylene in the range of 170 ° C is preferably used.
  • the density of the ethylene-olefin copolymer is particularly high in the marked range.
  • the MFR is preferably from 1.0 to 5.0 g / 10 min (190 ° C), and the melting point is preferably from 115 to 25 ° C.
  • the density of the ethylene-one-year-old olefin-based elastomer is particularly in the range of 0.870 to 0.890 g / cm 3 in the range of the title.
  • the MFR is preferably 0.1 to 2.0 g / 10 minutes (190 ° C).
  • the high-density polyethylene preferably has an MFR of 1 to 30 g / 10 minutes (190 ° C.).
  • the mixing ratio of the ethylene-polyolefin copolymer, the ethylene-polyolefin copolymer and the high-density polyethylene constituting the mixed resin (B) in the order of 35 to 55 in the range of the title %, 40 to 60% and 3 to 8% by weight.
  • Examples of the polypropylene, ethylene-one-year-old olefin-based elastomer, and high-density polyethylene which constitute the title mixed resin (C) include those having a density within the title range among the above examples.
  • isopropanol having an MFR of 1 to 40 g / 10 min (230 ° C) and a melting point of 140 to 170 ° C is used, as described above. It is preferably polypropylene.
  • the preferred range of the density, MFR or melting point of the ethylene-olefin-based elastomer and the high-density polyethylene is the same as described above.
  • the mixing ratio of the polypropylene, ethylene-one-year-old olefin-based elastomer and high-density polyethylene that make up the mixed resin (C) is 4 It is preferably 0-50% by weight, 45-55% by weight and 3-7% by weight. If the ratio of each resin constituting the above-mentioned mixed resin (C) is out of the above range, problems such as a decrease in flexibility and heat resistance, a decrease in moldability, and a decrease in pinhole resistance are caused. Occurs.
  • polypropylene and the ethylene / ethyl olefin elastomer which constitute the title mixed resin (D) those having the density within the title range among the above-mentioned examples are used.
  • the preferred range of the density, MFR or melting point of the polypropylene and the ethylene 'phosphorefin-based elastomer is the same as described above.
  • the mixing ratio of the polypropylene and the ethylene-based olefin-based elastomer constituting the mixed resin (D) is 40 to 50% by weight and 50 to 60% by weight, respectively, in the range of the title.
  • the first layer and the fifth layer in the multilayer film of the present invention are the layers that become the outer layer and the inner layer of the medical container, respectively.
  • the first layer (the outer layer) has mechanical strength (particularly, tensile strength) and heat resistance.
  • the fifth layer (inner layer) is required to have sealing properties and blocking resistance.
  • an ethylene / polyolefin copolymer having a density of 0.930 to 0.950 g / cm 3 is used.
  • the copolymers in particular density 0.9 35-0. 945 / Rei_111 3, 1? Those having an R of 1.0 to 5.0 g / 10 minutes (190 ° C) and a melting point in the range of 120 to 130 ° C are more excellent in the above properties and are more suitable.
  • the ratio of the thickness of the first layer (outer layer) is preferably 5 to 15%, more preferably 5 to 10%, based on the thickness of the entire film.
  • the mechanical strength and heat resistance of the multilayer film or the medical container may be insufficient. Conversely, even if the thickness exceeds the above range, there is no significant change in mechanical strength or heat resistance, and the flexibility of the multilayer film may be reduced.
  • the ratio of the thickness of the fifth layer is preferably from 7 to 20%, more preferably from 7 to 15%, based on the thickness of the entire film. If the ratio of the thickness of the fifth layer is below the above range, the sealing property of the multilayer film may be reduced, and the appearance of the container may be deteriorated. Conversely, even if the thickness exceeds the above range, there is no significant change in the sealing property and the blocking resistance, and the flexibility of the multilayer film may be reduced.
  • the second layer in the multilayer film of the present invention is one of three intermediate layers, and the mixed resin (B) or (C) is used to provide flexibility without impairing the heat resistance of the multilayer film. ) Is used.
  • the ratio of the thickness of the second layer is preferably 25 to 45%, more preferably 30 to 45%, based on the thickness of the entire film. If the thickness ratio is out of the above range, the flexibility of the multilayer film and the container may be insufficient, or the heat resistance / pinhole resistance may decrease.
  • the third layer in the multilayer film of the present invention is the most intermediate layer in the three-layer intermediate layer, and the ethylene used for the first layer and the fifth layer in order to maintain the strength of the multilayer film.
  • ⁇ ⁇ -refined copolymer ( ⁇ ) or mixed resin (D) is used.
  • the ratio of the thickness of the third layer is preferably 2 to 15% based on the thickness of the entire film. If the thickness ratio is out of the above range, the strength of the multilayer film and the container will be insufficient. W
  • the fourth layer in the multilayer film of the present invention is one of three intermediate layers, and the mixed resin is used to impart heat resistance while maintaining the flexibility of the multilayer film.
  • the ratio of the thickness of the fourth layer is preferably from 25 to 45%, more preferably from 30 to 45%, based on the thickness of the entire film.
  • the problem when the thickness ratio is out of the above range is the same as in the case of the second layer described above.
  • the multilayer film of the present invention by setting the layer structure, especially the structure of the intermediate layer (second to fourth layers) as described above, the flexibility (elasticity) of the entire film is maintained while the entire film is maintained. It is possible to maintain the strength of the steel, and to further improve the heat resistance.
  • a water-cooled or air-cooled coextrusion inflation method a coextrusion T-die method, a dry lamination method, an extruded lamination method, and the like can be used. It is preferable to use the water-cooled co-extrusion inflation method and co-extrusion T-die method in terms of transparency, economy and hygiene.
  • the temperature condition for producing the multilayer film of the present invention is usually from 150 to 250 ° C, preferably from 170 to 200 ° C.
  • the thickness of the film of the present invention produced as described above is generally 100 to 350 ⁇ m, preferably 200 to 300 m, but can be appropriately increased or decreased depending on the purpose of use and the like. Sufficient strength is maintained even with a thickness of about 250 m.
  • FIG. 1 showing one embodiment thereof. You.
  • FIG. 1 is a front view showing an example of a medical container (infusion bag).
  • the medical container 10 is obtained by cutting the two sheet-like multilayer films obtained as described above by an ordinary method, superimposing the respective fifth layers as inner layers, heat sealing the periphery of the container 10, and furthermore,
  • the container 10 having a predetermined shape and dimensions is manufactured by attaching the container 10 by means such as heat sealing.
  • the container 10 may be formed by heat sealing after being formed into a tube with the fifth layer of the multilayer film inside.
  • a condition for heat sealing the film a temperature range of 130 to 200 ° C. can be adopted. For example, in the case of a film having a thickness of about 250 It can be sealed in a short time of 0.5 to 6 seconds.
  • the member 20 a resin which is excellent in adhesion to the fifth layer in the multilayer film of the present invention, for example, a resin molded with polyethylene.
  • the heat sealing conditions are as follows. Heat for 5 to 5 seconds.
  • C-1 Mixed resin consisting of 45% by weight of polypropylene of (4), 50% by weight of elastomer of (2) and 5% by weight of high-density polyethylene of (3)
  • C-2 A mixed resin consisting of 41.5% by weight of the polypropylene of (4), 53.5% by weight of the elastomer of (2) and 5% by weight of the high-density polyethylene of (3).
  • C-3 A mixed resin comprising 30% by weight of the polypropylene of (4), 65% by weight of the elastomer of (2) and 5% by weight of the high-density polyethylene of (3).
  • C-4 Mixed resin consisting of 45% by weight of polypropylene of (4), 45% by weight of elastomer of (2) and 10% by weight of high-density polyethylene of (3)
  • D-1 Mixed resin consisting of 45% by weight of polypropylene of (4) and 55% by weight of elastomer of (2)
  • A-1 C-l A-1 C-l A-1 Example 2 20 ⁇ m 100 Aim 10 / m lOO ⁇ m 30 Am
  • A-1 D-l A-1 D-l A-1 Comparative Example 1 20 ⁇ 100 m 10 / m 100 ⁇ m 30 ⁇
  • A-1 B-l C-l A-1 Comparative Example 2 30 im 100 Mm 100 ⁇ 30 ⁇
  • A-1 C-3 A-1 C-3 A-1 Comparative example 3 20 m 100 ⁇ 10 m 100 ⁇ 30 ⁇
  • a medical container (infusion bag) 10 having a content of 50 Oml as shown in FIG. 1 was produced.
  • heat sealing of the peripheral portion was performed at 155 ° C for 4.5 seconds
  • sealing of the mouth member 20 was performed at 140 to 150 ° C for 3 seconds.
  • Drop test After refrigerated at about 4 ° C, the containers were dropped five times each from three directions from a height of 1 m, and the state of bag breakage and seal leakage was visually observed.
  • Example 1 Example 2
  • Example 3 Example 4
  • the container of the present invention obtained very good results in all of the items of heat resistance, drop test, flexibility, transparency and appearance.
  • a medical container (infusion bag) 10 obtained using the multilayer films of Examples 1 to 5 and Comparative Examples 1 to 3 was filled with a physiological saline solution, sealed with a rubber stopper, and kept at 110 ° C.
  • the autoclave was subjected to high-pressure steam sterilization for 40 minutes.
  • Comparative Example 2 which is a four-layer multilayer film and the mixed resin (C) used for the second and fourth layers which are the intermediate layers are out of the scope of the present invention.
  • Comparative Example 3 the proportion of specimens with pinholes was large, and the binhole resistance was not practically sufficient.
  • Comparative Example 1 in which the mixed resin used in the second and fourth layers, which are the intermediate layers, did not contain high-density polyethylene, the proportion of specimens with pinholes was 0%, The hole property was extremely excellent. However, the appearance was extremely inadequate, with many wrinkles observed after sterilization, making it unsuitable as a medical container.
  • a film having a layer structure shown in Table 4 below can be formed in the same manner as in Examples 1 to 5. These films also have the same excellent properties as described above. [Table 4] Upper: resin type, lower: thickness
  • Example 10 20 ⁇ 100 ⁇ 10 ⁇ 100 ⁇ 30um
  • the multilayer film and the container according to the present invention are excellent in heat resistance, blocking resistance, strength, sealability, transparency, flexibility and appearance, and furthermore have a binhole at a bent portion or the like during heat sealing. It has the advantage that no blood is generated, and can be suitably used as medical containers such as infusion bags and blood bags.

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Abstract

A multilayered film comprising five layers in which the first, third, and fifth layers are made of an ethylene/α-olefin copolymer having a density of 0.930 to 0.950 g/cm3 and the second and fourth layers are made of a resin blend comprising 35 to 55 wt.% polypropylene having a density of 0.900 to 0.930 g/cm3, 40 to 60 wt.% ethylene/α-olefin elastomer having a density of 0.860 to 0.900 g/cm3, and 2 to 8 wt.% high-density polyethylene having a density of 0.955 to 0.970 g/cm3; and a container made of the film (bag for fluid transfusion, etc.). The multilayered film and the container are useful in medical applications.

Description

明細書  Specification

多層フィルムおよび容器  Multilayer film and container

技術分野 Technical field

本発明は、 多層フィルムおよびそれを用いて成形された容器に関し、 より詳し くは、 医療の分野において、 特に薬液や血液等の収容用材料として用いられる多 層フィルムおよび容器に関する。 背景技術  The present invention relates to a multilayer film and a container formed using the same, and more particularly, to a multilayer film and a container used in the medical field, particularly as a material for containing a chemical solution, blood, and the like. Background art

輸液バッグ等の医療用可撓性プラスチック製容器は、 その性質を向上させるた めに、 素材として多層フィルムを採用することが試みられている。 従来の医療用 多層容器の例としては、 以下のポリエチレン系樹脂からなるものを挙げることが できる。  In order to improve the properties of medical flexible plastic containers such as infusion bags, it has been attempted to employ a multilayer film as a material. Examples of conventional multi-layer medical containers include those made of the following polyethylene resins.

1 ) 特開昭 62 - 64363号公報  1) JP-A-62-64363

直鎖状低密度ポリエチレンからなり、 内外層の密度が 0. 920 g/ cm3以上、 中間層の密度が 0. 920 g/ cm3未満である 3層の袋。 A three-layer bag made of linear low-density polyethylene, wherein the density of the inner and outer layers is 0.920 g / cm 3 or more, and the density of the middle layer is less than 0.920 g / cm 3 .

2 ) 特閧昭 63— 248633号公報  2) Japanese Patent Publication No. 63-248633

直鎖状低密度ポリエチレンからなる 3層で、 内外層の密度が 0. 9 10〜0. 940 g/cm\ 中間層の密度が 0. 880〜0. 905 g/cm3で、 両者の 密度差が 0. 0 1 g/ cm3以上である容器。 Three layers consisting of linear low density polyethylene, density 0.9 10-0 of the inner and outer layers. 940 g / cm \ density of the intermediate layer is 0.880 to 0. In 905 g / cm 3, both the density of the containers difference is that 0. 0 1 g / cm 3 or more.

3 ) 特開平 3— 277365号公報  3) JP-A-3-277365

外層が密度 0. 920 g/ cm3以上の直鎖状低密度ポリエチレン、 中間層が密 度 0. 9 1 5 g/ cm3以下の直鎖状低密度ポリエチレン、 内層が密度 0. 9 18 g/c m3以上の分岐状低密度ポリエチレンである 3層の袋。 Outer layer density 0. 920 g / cm 3 or more linear low density polyethylene, intermediate layer density 0. 9 1 5 g / cm 3 or less linear low density polyethylene, the inner layer density 0. 9 18 g Three-layer bag made of branched low-density polyethylene of / cm 3 or more.

4) 特開平 4— 26675 9号公報  4) JP-A-4-26675-9

内外層が密度 0. 930 g/c m3以下の長鎖分岐低密度ポリエチレンに密度 0 945 g/ cm3以上の高密度ポリエチレンを 5 ~40%混合した樹脂で、 中間層 が密度 0. 920 g/ cm3以下の直鎖状低密度ポリエチレンに上記高密度ポリエ チレンを 1 5%以下混合した樹脂からなる 3層以上のバッグ。 Inner and outer layers to the density 0. 930 g / cm 3 or less long chain branching low-density polyethylene Density 0 945 g / cm 3 or more high-density polyethylene with 5-40% mixed resin, the intermediate layer density 0. 920 g A bag of three or more layers made of a resin in which 15% or less of the high-density polyethylene is mixed with linear low-density polyethylene of / cm 3 or less.

ところが、 上記従来の医療用多層容器は、 以下のような欠点のいずれかを有し ている。 However, the conventional medical multilayer container has one of the following disadvantages. ing.

( i) フィルムの内外層が低密度のポリェチレン樹脂で構成されているために耐 熱性が充分でなく、 高圧蒸気滅菌や熱水滅菌等の高温条件での滅菌により、 シー ル強度および落下強度が低下する。  (i) The heat resistance is not sufficient because the inner and outer layers of the film are made of low-density polyethylene resin, and the seal strength and drop strength are reduced by sterilization under high-temperature conditions such as high-pressure steam sterilization and hot water sterilization. descend.

( ii )上記高温条件の滅菌後にブロッキングを起こし易い (耐ブロッキング性が 低い) 。  (ii) Blocking easily occurs after sterilization under the above-mentioned high temperature conditions (low blocking resistance).

( iii ) フィルムの強度が低いために、 肉厚を厚くする必要がある。  (iii) Since the strength of the film is low, it is necessary to increase the thickness.

( iv)フィルムの引張強度が充分ではないので、 製袋速度を上げることができな い。  (iv) The bag making speed cannot be increased because the tensile strength of the film is not sufficient.

( V ) ヒートシールする際にヒーターの温度を高くできないので、 短時間でシー ルできない (シール性が低い) 。  (V) Heating cannot be performed in a short time because the temperature of the heater cannot be raised during heat sealing (low sealing performance).

(vi )滅菌後等にフィルムの透明性や柔軟性が低下する。  (vi) The transparency and flexibility of the film are reduced after sterilization.

また、 図 1に示すような医療用容器 (輸液バッグ) 1 0を製造する場合、 フィ ルム 2 2を 2枚重ね合わせ、 ロ部材 (ポート) 2 0を 2枚のフィルム 2 2間に揷 入した状態で、 フィルム 2 2の周縁にヒートシールが施される。  When manufacturing a medical container (infusion bag) 10 as shown in FIG. 1, two films 22 are superimposed, and a member (port) 20 is inserted between the two films 22. In this state, the periphery of the film 22 is heat-sealed.

しかし、 図 2に示すように、 ロ部材 2 0の隣接部でフィルム 2 2が大きく屈曲 するため、 従来の多層フィルムを用いてヒートシールすると、 屈曲部 2 4でフィ ルムが伸びて膜厚が薄くなり、 ピンホールが発生するおそれがあった。  However, as shown in FIG. 2, since the film 22 bends greatly in the area adjacent to the member 20, when heat sealing is performed using a conventional multilayer film, the film expands at the bend 24 and the film thickness increases. It became thin, and pinholes might be generated.

そこで、 本発明の目的は、 耐熱性、 耐ブロッキング性、 強度、 シール性、 透明 性および柔軟性に優れており、 さらにヒートシール時に屈曲部にピンホールが発 生するのを防止できる多層フィルムおよび容器を提供することにある。 発明の開示  Therefore, an object of the present invention is to provide a multilayer film which is excellent in heat resistance, blocking resistance, strength, sealability, transparency and flexibility, and which can prevent generation of pinholes in a bent portion during heat sealing. It is to provide a container. Disclosure of the invention

発明者らは、 上記課題を解決するために鋭意研究を重ねていく中で、 中間層を 3層構造とした上で、 各々の層に配する樹脂または混合樹脂と、 多層フィルム全 体の層構成の組み合わせとについて種々の検討を行った結果、 透明性、 柔軟性等 の基本的な性質を損なうことなく、 耐熱性を向上することのできる全く新たな樹 脂組成とその配置の組合せとを見出し、 本発明を完成するに至った。  The inventors of the present invention have conducted intensive research to solve the above-mentioned problems, and have formed a three-layer structure of the intermediate layer, a resin or mixed resin disposed in each layer, and a layer of the entire multilayer film. As a result of various studies on the combination of configurations, a completely new resin composition that can improve the heat resistance without impairing the basic properties such as transparency and flexibility, and the combination of the arrangement of the resin were found. This led to the completion of the present invention.

すなわち、 本発明は、 5層からなる多層フィルムであって、 第 1層および第 5 層が(A)密度 0· 930〜 0. 950 g/cm3のエチレン · ひ一才レフイン共重 合体であり、 第 2層が(B)密度 0. 9 10〜0. 930 g/cm3のエチレン ' ひ —ォレフイ ン共重合体 30〜60重量%、 密度 0. 860〜0. 900 g/cm3 のエチレン ' ひ一才レフイン系エラストマ一 35〜65重量%および密度 0. 9 55〜0. 970 g/cm3の高密度ポリエチレン 1〜 10重量%からなる混合樹 脂、 または(C)密度 0. 900〜0. 930 g/cm3のポリプロピレン 35〜5 5重量%、 密度 0. 860〜0. 900 gZcm3のエチレン ' ひ一才レフイ ン系 エラストマ一 40〜60重量%および密度 0. 955〜0. 970 g/cm3の高 密度ポリエチレン 2~8重量%からなる混合樹脂であり、 第 3層が前記 (A) のェ チレン ' ひ一ォレフィン共重合体、 または(D) 密度 0. 900〜0. 930 g/ cm3のポリプロピレン 40~ 60重量%および密度 0. 860〜0. 900 g/ cm3のエチレン ·ひ一ォレフィン系エラストマ一 40~60重量%からなる混合 樹脂であり、 かつ第 4層が前記(C) の混合樹脂であることを特徴とする。 That is, the present invention relates to a multilayer film comprising five layers, Layer is the (A) Density 0 · 930~ 0. 950 g / cm 3 of ethylene flying one year old Refuin co polymer, the second layer (B) Density 0. 9 10~0. 930 g / cm 3 Ethylene-Hyperolefin copolymer 30-60% by weight, Density 0.860-0.900 g / cm 3 Ethylene olefin elastomer 35-65% by weight and Density 0.955- 0. 970 g / cm 3 in the mixed resins consisting of high density polyethylene 1-10 wt%, or, (C) density 0. 900~0. 930 g / cm 3 polypropylene 35-5 5 wt%, density 0. A mixed resin consisting of 860-0.900 gZcm 3 of ethylene '' one-year-old refin-based elastomer 40-60% by weight and density 0.955-5.970 g / cm 3 High-density polyethylene 2-8% by weight And the third layer is the above-mentioned (A) the ethylene'polyolefin copolymer, or (D) the polypropylene having a density of 0.900 to 0.930 g / cm 3 40 to 60% by weight and the density of 0.860 to 0. of 900 g / cm 3 ethylene-Fei one Orefu A mixed resin comprising 40 to 60% by weight of an epoxy-based elastomer, and the fourth layer is the mixed resin of the above (C).

上記本発明の多層フィルムによれば、 前述の医療用容器 (輸液バッグ) 10を 製造する際等において、 ビンホールが発生するのを十分に防止できる。 特に、 ポ —卜 20の熱溶着を比較的高い温度で行うことができ、 かつ屈曲部 24でフィル ムが伸び過ぎることがないので、 当該屈曲部 24におけるビンホールの発生を確 実に防止できる。 図面の簡単な説明  According to the multilayer film of the present invention described above, it is possible to sufficiently prevent the occurrence of binholes, for example, when manufacturing the medical container (infusion bag) 10 described above. In particular, since the heat welding of the port 20 can be performed at a relatively high temperature, and the film does not extend too much at the bent portion 24, it is possible to reliably prevent the occurrence of a binhole at the bent portion 24. BRIEF DESCRIPTION OF THE FIGURES

図 1は、 本発明の容器の一実施形態を示す正面図である。  FIG. 1 is a front view showing an embodiment of the container of the present invention.

図 2は、 図 1の A— A部分断面図である。  FIG. 2 is a partial cross-sectional view taken along line AA of FIG.

符号の説明  Explanation of reference numerals

10 容器  10 containers

20 ロ部材 発明を実施するための最良の形態  20 Best Mode for Carrying Out the Invention

本発明の多層フィルムは、 上記の中でも、 第 2層が前記(C)の混合樹脂であり、 かつ第 3層が前記(A) のエチレン ' ひ—ォレフィ ン共重合体であるのが、 十分な 耐熱性を保持しつつ、 製造コストを低減するという観点から好ましい。 In the multilayer film of the present invention, among the above, it is sufficient that the second layer is the mixed resin of the above (C), and the third layer is the ethylene 'olefin copolymer of the above (A). What This is preferable from the viewpoint of reducing manufacturing costs while maintaining heat resistance.

また、 本発明の多層フィルムにおいて、 前記(C) または(D) の混合樹脂に用い られるポリプロピレンは、 そのメルトフローレート (MFR) が l〜40 g/l 0分 ( 230°C) で、 その融点が 140〜 1 70°Cであるのが、 他の樹脂との親 和性等の点から好ましい。  In the multilayer film of the present invention, the polypropylene used for the mixed resin (C) or (D) has a melt flow rate (MFR) of 1 to 40 g / l 0 min (230 ° C), A melting point of 140 to 170 ° C. is preferred from the viewpoint of compatibility with other resins.

本発明の多層フィルムにおける各層の厚みの割合は、 フィルム全体の厚みに対 して、 第 1層が 5〜 15%、 第 2層が 25〜45%、 第 3層が 2〜 15%、 第 4 層が 25~45%および第 5層が 7~20 %の範囲であるのが好ましく、 さらに 第 1層が 5~10%、 第 2層が 30〜45%、 第 3層が 2〜 10%、 第 4層が 3 0〜45%および第 5層が?〜 1 5%の範囲であるのがより好ましい。  The proportion of the thickness of each layer in the multilayer film of the present invention is 5 to 15% for the first layer, 25 to 45% for the second layer, 2 to 15% for the third layer, It is preferable that the fourth layer has a range of 25 to 45% and the fifth layer has a range of 7 to 20% .The first layer has a range of 5 to 10%, the second layer has a range of 30 to 45%, and the third layer has a range of 2 to 10%. %, The fourth layer is 30-45% and the fifth layer? More preferably, it is in the range of 15%.

本発明の容器は、 上記の多層フィルムのいずれかを用い、 当該多層フィルムの 第 1層を外層とし、 第 5層を内層として成形されていることを特徴とする。  The container of the present invention is characterized in that any one of the above-mentioned multilayer films is used, and the first layer of the multilayer film is formed as an outer layer and the fifth layer is formed as an inner layer.

上記本発明の容器は、本発明の多層フィルムを用いて成形されていることから、 耐熱性が高く、 耐ブロッキング性、 強度、 シール性、 柔軟性および透明性が良好 で、 ビンホールの発生を十分に防止することのできるものとなる。  Since the container of the present invention is formed by using the multilayer film of the present invention, it has high heat resistance, good blocking resistance, strength, sealing property, flexibility and transparency, and sufficient generation of bin holes. Can be prevented.

以下、 本発明の多層フィルムおよび容器における各層の樹脂と、 本発明の多層 フィルムおよび容器の製造方法について詳細に説明する。  Hereinafter, the resin of each layer in the multilayer film and the container of the present invention and the method for producing the multilayer film and the container of the present invention will be described in detail.

なお、 本発明において規定した物性値はいずれも The American Society for Testing and Materials (ASTM) 規定に基づいたものであって、 密度は AS TM D 1 505、 メルトフローレート (MFR) は AS TM D 1238、 融 点は AS TM D 2 1 17に準じて測定したものである。  The physical properties specified in the present invention are all based on the rules of the American Society for Testing and Materials (ASTM), and the density is ASTM D1505 and the melt flow rate (MFR) is ASTM D1238. The melting point is measured according to ASTM D2117.

まず、 本発明の多層フィルムに使用される樹脂、 共重合体およびエラストマ一 について説明する。  First, the resin, copolymer and elastomer used in the multilayer film of the present invention will be described.

〔エチレン · ひ一ォレフィン共重合体およびエチレン · ひーォレフィン系エラ ストマ一〕  [Ethylene-Hiorefin Copolymer and Ethylene-Hiorefin Elastomer]

標記共重合体またはエラストマ一におけるひ一才レフィンとしては、 例えばプ ロピレン、 1ーブテン、 1一ペンテン、 1一へキセン、 4—メチル一 1—ペンテ ン、 1—ヘプテン、 1一才クテン、 1—ノネン、 1ーデセン、 1—ゥンデセン、 1 -ドデセン等の炭素数が 3〜 1 2のひ一ォレフィンが挙げられる。 標記共重合体またはエラストマ一は、 特に中低圧法により製造された、 分岐鎖 が単鎖であるものがより好適に用いられる。 Examples of olefins in the title copolymer or elastomer include propylene, 1-butene, 1-pentene, 1-hexene, 4-methyl-1-1-pentene, 1-heptene, 1-octene, 1-octene —Oneolefin having 3 to 12 carbon atoms, such as —nonene, 1-decene, 1-decene, and 1-dodecene. As the title copolymer or elastomer, those having a single branched chain produced by a medium-to-low pressure method are particularly preferably used.

〔高密度ポリエチレン〕  (High-density polyethylene)

標記高密度ポリエチレンは、 エチレンのホモポリマーのほか、 ひ一ォレフィン との共重合体であってもよい。 ひ一ォレフィンとしては、 前記例示の炭素数 3〜 12のひ一ォレフィンが挙げられる。 また、 ひ一ォレフィンの含有割合は、 特に 限定されないが、 通常 0. 1〜5モル%の範囲で設定される。  The high-density polyethylene described above may be a homopolymer of ethylene or a copolymer with ethylene glycol. Examples of the monorefin include the above-mentioned monorefin having 3 to 12 carbon atoms. Although the content ratio of the monoolefin is not particularly limited, it is usually set in the range of 0.1 to 5 mol%.

本発明に用いられる高密度ポリエチレンは密度が 0. 955〜0. 970 g/ cm3の範囲のものであるが、 中でも MFRが 1〜30 g/ 10分 ( 1 90°C) で あるものが好適である。 標記ポリプロピレンは、 プロピレンのホモポリマーのほか、 エチレンや α—ォ レフインを少量含有する共重合体であってもよい。 ひ一才レフインとしては、 例 えば 1ーブテン等の、 前記例示のひ一才レフィンのうち炭素数が 4〜 12程度の ひ一才レフインが挙げられる。 また、 ひ一才レフインの含有割合は、 通常 10重 量%以下の範囲で設定される。 The high-density polyethylene used in the present invention has a density in the range of 0.955 to 0.970 g / cm 3 , and among them, one having an MFR of 1 to 30 g / 10 minutes (190 ° C) It is suitable. The title polypropylene may be a homopolymer of propylene or a copolymer containing a small amount of ethylene or α-olefin. As the one-year-old refin, for example, the one-year-old fin having the carbon number of about 4 to 12 among the above-mentioned one-year-old fins such as 1-butene is exemplified. In addition, the content ratio of Hiichi Sai Refin is usually set within the range of 10% by weight or less.

本発明に用いられるポリプロピレンは密度が 0. 900〜0. 930 g/cm3 の範囲のものであるが、 中でも MFRが 1〜40 g/ 10分 (230°C) で、 融 点が 140~ 170°Cの範囲にあるアイソタクティックポリプロピレンが好適に 用いられる。 The polypropylene used in the present invention has a density in the range of 0.900 to 0.930 g / cm 3 , especially having an MFR of 1 to 40 g / 10 minutes (230 ° C) and a melting point of 140 to Isotactic polypropylene in the range of 170 ° C is preferably used.

次に、 本発明の多層フィルムを構成する混合樹脂について説明する。  Next, the mixed resin constituting the multilayer film of the present invention will be described.

〔密度 0. 9 10~0. 930 g/cm3のエチレン . ひ一ォレフィン共重合体 30~ 60重量%、 密度 0. 860〜0. 900 g/cm3のエチレン ' ひーォレ フィ ン系エラストマ一 35〜65重量%および密度 0. 955〜0. 970 g/ cm3の高密度ポリエチレン 1~ 10重量%からなる混合樹脂 (混合樹脂 (B) ) 〕 標記混合樹脂(B) を構成するエチレン · ひ—ォレフィン共重合体、 エチレン ' ひ一才レフィン系エラストマ一および高密度ポリエチレンとしては、 前記例示の うち、 その密度が標記範囲内にあるものが用いられる。 [Density 0.9 10-0. Ethylene 930 g / cm 3. Fei one Orefin copolymer 30-60 wt%, a density from 0.860 to 0. Of 900 g / cm 3 Ethylene 'shed Ore Fi down elastomers ethylene, which constitutes one 35-65 wt% and density 0. 955~0. 970 g / cm 3 density polyethylene 1-10 wt% of a mixed resin (mixed resin (B))] the title mixed resin (B) · As the polyolefin copolymer, ethylene ′, a polyolefin elastomer and a high-density polyethylene, those having a density within the specified range among the above-mentioned examples are used.

前記エチレン ' ひ一才レフイン共重合体は、 その密度が、 標記範囲の中でも特 W The density of the ethylene-olefin copolymer is particularly high in the marked range. W

に 0. 9 1 5〜0. 925 g/ cm3であるのが好ましい。 また、 その MFRは 1. 0~5. 0 g/10分( 1 90°C)であるのが好ましく、融点は 1 1 5〜 : L 25°C であるのが好ましい。 Preferably a 0. 9 1 5~0. 925 g / cm 3 in. The MFR is preferably from 1.0 to 5.0 g / 10 min (190 ° C), and the melting point is preferably from 115 to 25 ° C.

前記エチレン ' ひ一才レフイン系エラストマ一は、 その密度が、 標記範囲の中 でも特に 0. 870〜0. 890 g/cm3であるのが好ましい。 また、 その MF Rは 0. 1〜2. 0 g/ 1 0分 ( 190°C) であるのが好ましい。 It is preferable that the density of the ethylene-one-year-old olefin-based elastomer is particularly in the range of 0.870 to 0.890 g / cm 3 in the range of the title. Further, the MFR is preferably 0.1 to 2.0 g / 10 minutes (190 ° C).

前記高密度ポリエチレンは、 その MFRが 1〜30 g/10分 ( 190°C) で あるのが好ましい。  The high-density polyethylene preferably has an MFR of 1 to 30 g / 10 minutes (190 ° C.).

標記混合樹脂(B) を構成するエチレン ' ひ—ォレフィ ン共重合体、 エチレン ' ひ一才レフイ ン系エラストマ一および高密度ポリエチレンの混合割合は、 標記範 囲の中でも、 順に 35〜5 5重量%、 40〜60重量%および 3〜 8重量%であ るのが好ましい。  The mixing ratio of the ethylene-polyolefin copolymer, the ethylene-polyolefin copolymer and the high-density polyethylene constituting the mixed resin (B) in the order of 35 to 55 in the range of the title %, 40 to 60% and 3 to 8% by weight.

標記混合樹脂 (B) を構成する各樹脂等の比率が上記範囲を外れると、 柔軟性や 耐熱性が低下したり、 成形性が悪くなつたり、 耐ピンホール性が低下する等の問 題が生じる。  If the proportion of each resin constituting the mixed resin (B) is out of the above range, problems such as a decrease in flexibility and heat resistance, a decrease in moldability, and a decrease in pinhole resistance are caused. Occurs.

〔密度 0. 900〜0. 930 g/cm3のポリプロピレン 35~55重量%、 密度 0. 860〜0. 900 g/cm3のエチレン ' ひ一ォレフィ ン系エラストマ ー40〜60重量%および密度 0. 9 55 ~ 0. 970 g / c m3の高密度ポリエ チレン 2〜 8重量%からなる混合樹脂 (混合樹脂(C) ) 〕 [Density 0. 900~0. 930 g / cm Polypropylene 35 3 to 55 wt%, density 0. 860~0. 900 g / cm 3 of ethylene 'shed one Orefi emissions based elastomers 40-60 wt% and density 0. 9 55 ~ 0. 970 g / cm 3 of density polyethylene having 2 to a mixed resin consisting of 8 wt% (mixed resin (C))]

標記混合樹脂(C) を構成するポリプロピレン、 エチレン · ひ一才レフイン系ェ ラストマーおよび高密度ポリエチレンとしては、 前記例示のうち、 その密度が標 記範囲内にあるものが用いられる。  Examples of the polypropylene, ethylene-one-year-old olefin-based elastomer, and high-density polyethylene which constitute the title mixed resin (C) include those having a density within the title range among the above examples.

前記ポリプロピレンは、 その密度が標記範囲にあるものの中でも特に、 前述の ように MFRが 1〜40 g/ 10分( 230°C)で、かつ融点が 140〜 170 °C の範囲にあるアイソ夕クティ ヅクポリプロピレンであるのが好ましい。  Among the polypropylenes whose density is in the specified range, isopropanol having an MFR of 1 to 40 g / 10 min (230 ° C) and a melting point of 140 to 170 ° C is used, as described above. It is preferably polypropylene.

エチレン · ひ一ォレフィン系エラストマ一および高密度ポリエチレンの密度、 MFRまたは融点の好適範囲は前記と同じである。  The preferred range of the density, MFR or melting point of the ethylene-olefin-based elastomer and the high-density polyethylene is the same as described above.

標記混合樹脂(C) を構成するポリプロピレン、 エチレン · ひ一才レフイ ン系ェ ラストマ一および高密度ポリエチレンの混合割合は、 標記範囲の中でも、 順に 4 0〜50重量%、 45〜5 5重量%および 3 ~7重量%であるのが好ましい。 標記混合樹脂 (C) を構成する各樹脂等の比率が上記範囲を外れると、 柔軟性や 耐熱性が低下したり、 成形性が悪くなつたり、 耐ピンホール性が低下する等の問 題が生じる。 The mixing ratio of the polypropylene, ethylene-one-year-old olefin-based elastomer and high-density polyethylene that make up the mixed resin (C) is 4 It is preferably 0-50% by weight, 45-55% by weight and 3-7% by weight. If the ratio of each resin constituting the above-mentioned mixed resin (C) is out of the above range, problems such as a decrease in flexibility and heat resistance, a decrease in moldability, and a decrease in pinhole resistance are caused. Occurs.

特に、 高密度ポリエチレンの混合割合が上記範囲を超えると、 成形が困難にな つてフィルムが得られなくなる。 逆に、 上記範囲を下回ると、 多層フィルムを用 いて容器を成形したときに多数のしわが生じる等、 外観上の問題が生じる。  In particular, if the mixing ratio of the high-density polyethylene exceeds the above range, molding becomes difficult and a film cannot be obtained. Conversely, when the ratio is below the above range, appearance problems such as a large number of wrinkles are generated when the container is formed using the multilayer film.

〔密度 0. 900〜0. 930 g/cm3のポリプロピレン 40〜60重量%お よび密度 0. 860~ 0. 900 g/cm3のエチレン ' ひ一ォレフィン系エラス トマ一 40〜60重量%からなる混合樹脂 (混合樹脂 (D) ) 〕 [Density from 0. 900~0. 930 g / cm Polypropylene 40-60 of 3 wt% Contact and density 0. 860 ~ 0. 900 g / cm 3 of ethylene 'shed one Orefin system Elastica Tomah one 40-60 wt% Mixed resin (Mixed resin (D))

標記混合樹脂(D) を構成するポリプロピレンおよびエチレン · ひ一才レフイン 系エラストマ一としては、 前記例示のうち、 その密度が標記範囲内にあるものが 用いられる。  As the polypropylene and the ethylene / ethyl olefin elastomer which constitute the title mixed resin (D), those having the density within the title range among the above-mentioned examples are used.

ポリプロピレンおよびエチレン ' ひーォレフィン系エラストマ一の密度、 MF Rまたは融点の好適範囲は前記と同じである。  The preferred range of the density, MFR or melting point of the polypropylene and the ethylene 'phosphorefin-based elastomer is the same as described above.

標記混合樹脂(D) を構成するポリプロピレンおよびエチレン ' ひ一才レフイン 系エラストマ一の混合割合は、 標記範囲の中でも、 順に 40〜50重量%ぉよび 50〜 60重量%であるのが好ましい。  It is preferable that the mixing ratio of the polypropylene and the ethylene-based olefin-based elastomer constituting the mixed resin (D) is 40 to 50% by weight and 50 to 60% by weight, respectively, in the range of the title.

標記混合樹脂 (D) を構成する各樹脂等の比率が上記範囲を外れると、 強度が低 下したり、 耐ビンホール性が低下する等の問題が生じる。  If the ratio of each resin constituting the mixed resin (D) is out of the above range, problems such as a decrease in strength and a decrease in binhole resistance occur.

次に、 本発明の多層フィルムの各層について説明する。  Next, each layer of the multilayer film of the present invention will be described.

〔第 1層および第 5層〕  (First and fifth layers)

本発明の多層フィルムにおける第 1層および第 5層は、 それそれ医療用容器の 外層および内層になる層であって、 第 1層 (外層) には機械強度 (とりわけ、 引 張強度) および耐熱性が、 第 5層 (内層) にはシール性および耐ブロッキング性 がそれそれ要求される。  The first layer and the fifth layer in the multilayer film of the present invention are the layers that become the outer layer and the inner layer of the medical container, respectively. The first layer (the outer layer) has mechanical strength (particularly, tensile strength) and heat resistance. The fifth layer (inner layer) is required to have sealing properties and blocking resistance.

第 1層および第 5層には、 上記の性質を兼ね備えた樹脂として、 密度が 0. 9 30〜0. 9 50 g/cm3であるエチレン · ひ一ォレフィン共重合体が用いられ る。 前記共重合体の中でも、 特に密度が 0. 9 35〜0. 945 /〇1113で、 1 ? Rが 1 · 0〜5. 0 g/ 1 0分 ( 1 90°C) で、 かつ融点が 1 20〜 1 30°Cの 範囲であるものは、 上記の性質がさらに優れており、 より好適に用いられる。 第 1層 (外層) の厚みの割合は、 フィルム全体の厚みに対し、 5〜 1 5 %であ るのが好ましく、 5~ 1 0 %であるのがより好ましい。 第 1層の厚みの割合が上 記範囲を下回ると、 多層フィルムや医療用容器の機械強度や耐熱性が不十分にな るおそれがある。 逆に、 上記範囲を超えて厚くしても機械強度や耐熱性に大きな 変化はなく、 かえって多層フィルムの柔軟性が低下するおそれがある。 For the first layer and the fifth layer, as a resin having the above properties, an ethylene / polyolefin copolymer having a density of 0.930 to 0.950 g / cm 3 is used. Among the copolymers, in particular density 0.9 35-0. 945 / Rei_111 3, 1? Those having an R of 1.0 to 5.0 g / 10 minutes (190 ° C) and a melting point in the range of 120 to 130 ° C are more excellent in the above properties and are more suitable. Used for The ratio of the thickness of the first layer (outer layer) is preferably 5 to 15%, more preferably 5 to 10%, based on the thickness of the entire film. If the ratio of the thickness of the first layer is below the above range, the mechanical strength and heat resistance of the multilayer film or the medical container may be insufficient. Conversely, even if the thickness exceeds the above range, there is no significant change in mechanical strength or heat resistance, and the flexibility of the multilayer film may be reduced.

一方、 第 5層(内層)の厚みの割合は、 フィルム全体の厚みに対し、 7~20% であるのが好ましく、 7〜 1 5 %であるのがより好ましい。 第 5層の厚みの割合 が上記範囲を下回ると、 多層フィルムのシール性が低下して、 容器の外観が劣化 するおそれがある。 逆に、 上記範囲を超えて厚く してもシール性ゃ耐ブロッキン グ性に大きな変化はなく、 かえって多層フィルムの柔軟性が低下するおそれがあ る。  On the other hand, the ratio of the thickness of the fifth layer (inner layer) is preferably from 7 to 20%, more preferably from 7 to 15%, based on the thickness of the entire film. If the ratio of the thickness of the fifth layer is below the above range, the sealing property of the multilayer film may be reduced, and the appearance of the container may be deteriorated. Conversely, even if the thickness exceeds the above range, there is no significant change in the sealing property and the blocking resistance, and the flexibility of the multilayer film may be reduced.

〔第 2層〕  (2nd layer)

本発明の多層フィルムにおける第 2層は、 3層からなる中間層の 1つであって、 多層フィルムの耐熱性を損なうことなく、 柔軟性を与えるために、 前記混合樹脂 (B) または(C) が用いられる。  The second layer in the multilayer film of the present invention is one of three intermediate layers, and the mixed resin (B) or (C) is used to provide flexibility without impairing the heat resistance of the multilayer film. ) Is used.

第 2層の厚みの割合は、 フィルム全体の厚みに対し、 2 5〜45 %であるのが 好ましく、 30〜45 %であるのがより好ましい。 厚みの割合が上記範囲を外れ ると、 多層フィルムおよび容器の柔軟性が不十分になったり、 耐熱性ゃ耐ピンホ —ル性が低下したりするおそれがある。  The ratio of the thickness of the second layer is preferably 25 to 45%, more preferably 30 to 45%, based on the thickness of the entire film. If the thickness ratio is out of the above range, the flexibility of the multilayer film and the container may be insufficient, or the heat resistance / pinhole resistance may decrease.

〔第 3層〕  (3rd layer)

本発明の多層フィルムにおける第 3層は、 3層からなる中間層の中でも最も中 間に位置する層であって、 多層フィルムの強度を保っために、 第 1層および第 5 層に用いられるエチレン · α—才レフィン共重合体 (Α) 、 または混合樹脂(D) が 用いられる。  The third layer in the multilayer film of the present invention is the most intermediate layer in the three-layer intermediate layer, and the ethylene used for the first layer and the fifth layer in order to maintain the strength of the multilayer film. · Α-refined copolymer (Α) or mixed resin (D) is used.

第 3層の厚みの割合は、 フィルム全体の厚みに対し、 2〜 1 5 %であるのが好 ましい。 厚みの割合が上記範囲を外れると、 多層フィルムおよび容器の強度が不 W The ratio of the thickness of the third layer is preferably 2 to 15% based on the thickness of the entire film. If the thickness ratio is out of the above range, the strength of the multilayer film and the container will be insufficient. W

十分になったり、 あるいは強度が維持されても柔軟性が損なわれたりするおそれ がある。 It may be insufficient or the flexibility may be impaired even if the strength is maintained.

〔第 4層〕  (4th layer)

本発明の多層フィルムにおける第 4層は、 3層からなる中間層の 1つであって、 多層フィルムの柔軟性を維持しつつ、 耐熱性を付与するため、 前記混合樹脂 ©が 用いられる。  The fourth layer in the multilayer film of the present invention is one of three intermediate layers, and the mixed resin is used to impart heat resistance while maintaining the flexibility of the multilayer film.

第 4層の厚みの割合は、 フィルム全体の厚みに対し、 2 5〜4 5 %であるのが 好ましく、 3 0〜4 5 %であるのがより好ましい。 厚みの割合が上記範囲を外れ たときの問題点は、 前述の第 2層の場合と同じである。  The ratio of the thickness of the fourth layer is preferably from 25 to 45%, more preferably from 30 to 45%, based on the thickness of the entire film. The problem when the thickness ratio is out of the above range is the same as in the case of the second layer described above.

本発明の多層フィルムによれば、 層構成、 とりわけ中間層 (第 2 ~ 4層) の構 成を前述のように設定することにより、 フィルム全体の柔軟性 (弾性) を維持し つつ、 フィルム全体の強度を保持することが可能になり、 さらに耐熱性を向上さ せることが可能になる。  According to the multilayer film of the present invention, by setting the layer structure, especially the structure of the intermediate layer (second to fourth layers) as described above, the flexibility (elasticity) of the entire film is maintained while the entire film is maintained. It is possible to maintain the strength of the steel, and to further improve the heat resistance.

従って、 過酷な条件でのピンホール試験や落下試験にも十分に耐え得る、 安全 な容器を提供することができる。  Therefore, it is possible to provide a safe container that can sufficiently withstand a pinhole test and a drop test under severe conditions.

次に、 本発明の多層フィルムの製造方法について説明する。  Next, a method for producing the multilayer film of the present invention will be described.

本発明の多層フィルムを製造するには、 水冷式または空冷式共押出しィンフレ ーシヨン法、 共押出し Tダイ法、 ドライラミネーシヨン法、 押出しラミネ一ショ ン法等が使用可能であるが、 性能、 特に透明性、 経済性および衛生性等の点から 水冷共押出しインフレーション法および共押出し Tダイ法を使用するのが好まし い。  In order to produce the multilayer film of the present invention, a water-cooled or air-cooled coextrusion inflation method, a coextrusion T-die method, a dry lamination method, an extruded lamination method, and the like can be used. It is preferable to use the water-cooled co-extrusion inflation method and co-extrusion T-die method in terms of transparency, economy and hygiene.

いずれの方法においても、各層の樹脂が溶融する温度で実施する必要があるが、 温度を上げ過きると樹脂の一部が熱劣化を起こし、 劣化物による性能低下のおそ れが生じる。 従って、 本発明の多層フィルムを製造する際の温度条件は、 通常 1 5 0〜2 5 0 °C、 好ましくは 1 7 0 ~ 2 0 0 °Cとするのが望ましい。  In either method, it is necessary to carry out the process at a temperature at which the resin in each layer melts. However, if the temperature is excessively increased, a part of the resin undergoes thermal deterioration, and the performance may deteriorate due to the degraded material. Therefore, the temperature condition for producing the multilayer film of the present invention is usually from 150 to 250 ° C, preferably from 170 to 200 ° C.

上記により製造される本発明フィルムの厚みは、 一般に 1 0 0 ~ 3 5 0 ^ m、 好ましくは 2 0 0〜3 0 0 mであるが、 使用目的等に応じて適宜増減すること ができ、 2 5 0 m程度の厚みでも充分な強度を保持している。  The thickness of the film of the present invention produced as described above is generally 100 to 350 ^ m, preferably 200 to 300 m, but can be appropriately increased or decreased depending on the purpose of use and the like. Sufficient strength is maintained even with a thickness of about 250 m.

次に、 本発明の容器について、 その一実施形態を示す図 1を参照しつつ説明す る。 Next, the container of the present invention will be described with reference to FIG. 1 showing one embodiment thereof. You.

図 1は、 医療用容器 (輸液バッグ) の一例を示す正面図である。  FIG. 1 is a front view showing an example of a medical container (infusion bag).

医療用容器 1 0は、 上記により得られるシート状の多層フィルム 2枚を通常の 方法により裁断し、 それぞれの第 5層を内層として重ね合わせ、 容器 10の周縁 をヒートシールし、 さらにロ部材 20をヒートシール等の手段により取付けるこ とによって、 所定の形状および寸法の容器 1 0が製造される。 また、 多層フィル ムの第 5層を内側にしてチューブ状に成形した上で、 ヒートシールにより容器 1 0を成形してもよい。 ここで、 フィルムのヒートシールの条件としては、 130 〜200°Cの温度範囲を採用することができ、 例えば 2 5 0〃m程度の厚さを有 するフィルムの場合、 前記の温度範囲では約 0. 5 ~ 6秒という短い時間でシー ルできる。  The medical container 10 is obtained by cutting the two sheet-like multilayer films obtained as described above by an ordinary method, superimposing the respective fifth layers as inner layers, heat sealing the periphery of the container 10, and furthermore, The container 10 having a predetermined shape and dimensions is manufactured by attaching the container 10 by means such as heat sealing. Alternatively, the container 10 may be formed by heat sealing after being formed into a tube with the fifth layer of the multilayer film inside. Here, as a condition for heat sealing the film, a temperature range of 130 to 200 ° C. can be adopted. For example, in the case of a film having a thickness of about 250 It can be sealed in a short time of 0.5 to 6 seconds.

ロ部材 2 0には、 本発明の多層フィルムにおける第 5層との溶着性に優れた樹 脂、 例えばポリエチレンで成形したものを用いるのが好ましい。 ロ部材 20を融 点約 1 20〜 1 30°Cのポリエチレン製とした場合のヒートシールの条件として は、 口部材を数秒間予備加熱した上で、 約 140〜 1 70°Cで約 0. 5〜5秒間 の範囲で加熱すればよい。 実施例  It is preferable to use, as the member 20, a resin which is excellent in adhesion to the fifth layer in the multilayer film of the present invention, for example, a resin molded with polyethylene. (B) When the member 20 is made of polyethylene having a melting point of about 120 to 130 ° C, the heat sealing conditions are as follows. Heat for 5 to 5 seconds. Example

以下、 実施例、 比較例および試験例を挙げて本発明の多層フィルムおよび容器 を説明する。  Hereinafter, the multilayer film and the container of the present invention will be described with reference to Examples, Comparative Examples, and Test Examples.

実施例および比較例に使用した混合樹脂を構成する成分は次の通りである。 〔エチレン . ひ一ォレフィン共重合体〕  The components constituting the mixed resin used in the examples and comparative examples are as follows. [Ethylene / Hiolefin Copolymer]

(1) エチレン ' 1ーブテン共重合体 〔三井化学 (株) 製、 密度 = 0. 9 20 g /cm MFR = 2. 1 g/ 1 0分 ( 1 90 °C) 〕  (1) Ethylene 1-butene copolymer [Mitsui Chemicals Co., Ltd., density = 0.920 g / cm MFR = 2.1 g / 10 minutes (190 ° C)]

〔エチレン · ひーォレフイン系エラストマ一〕  (Ethylene / Hyorefin-based elastomer)

(2) エチレン ' 1—ブテン共重合体エラストマ一 〔三井化学 (株) 製、 密度 = 0. 885 g/cm3 、 MFR= 0. 5 /1 0分 ( 1 9 0°0〕 (2) Ethylene '1-butene copolymer elastomer [Mitsui Chemicals Co., Ltd., density = 0.885 g / cm 3 , MFR = 0.5 / 10 minutes (190 ° 0]

〔高密度ポリエチレン〕  (High-density polyethylene)

(3) エチレン ' 1—ブテン共重合体 〔三井化学 (株) 製、 密度 = 0. 9 62 g /cm3、 MFR= 1 5 g/1 0分 ( 1 90 °C) 〕 (3) Ethylene 1-butene copolymer [Mitsui Chemicals, Inc., density = 0.962 g / cm 3 , MFR = 15 g / 10 min (1 90 ° C)]

〔ポリプロピレン〕  (Polypropylene)

(4) ァイソタクティックポリプロピレン (エチレン含量: 5重量%以下) 〔三 井化学(株)製、密度二 0, 9 1 0 g/cm3、 MFR= 1. 6/1 0分(230°C)〕 表 1に示す樹脂は、 それそれ次のとおりである。 (4) Isotactic polypropylene (ethylene content: 5% by weight or less) [manufactured by Mitsui Chemicals, Inc., density: 2,910 g / cm 3 , MFR = 1.6 / 10 minutes (230 ° C)] The resins shown in Table 1 are as follows.

〔前記 (A) のエチレン · ひ一ォレフィン共重合体〕  (Ethylene / hydrophorin copolymer of the above (A))

A - 1 : エチレン · 1—ブテン共重合体 〔三井化学 (株) 製、 密度 = 0. 940 g/cm3、 MFR= 2. 1 g/ 1 0分 ( 1 90 °C) 〕 A-1: Ethylene / 1-butene copolymer [Mitsui Chemicals Co., Ltd., density = 0.940 g / cm 3 , MFR = 2.1 g / 10 min (190 ° C)]

〔前記 (B) の混合樹脂〕  (The mixed resin of the above (B))

B-1 :上記(1) の共重合体 45重量%、 上記(2) のエラストマ一 5 0重量%ぉ よび上記(3) の高密度ポリエチレン 5重量%からなる混合樹脂 (混合樹脂の密度 = 0. 90 6 g/cm3 ) B-1: A mixed resin composed of 45% by weight of the copolymer of (1), 50% by weight of the elastomer of (2), and 5% by weight of high-density polyethylene of (3) (density of mixed resin = 0.96 g / cm 3 )

〔前記 (C) の混合樹脂〕  (The mixed resin of the above (C))

C-1 :上記(4) のポリプロピレン 45重量%、 上記(2) のエラストマ一 50重 量%および上記(3) の高密度ポリエチレン 5重量%からなる混合樹脂  C-1: Mixed resin consisting of 45% by weight of polypropylene of (4), 50% by weight of elastomer of (2) and 5% by weight of high-density polyethylene of (3)

C-2 :上記(4) のポリプロピレン 4 1. 5重量%、 上記(2) のエラス トマ一 5 3. 5重量%および上記(3) の高密度ポリエチレン 5重量%からなる混合樹脂 C-2: A mixed resin consisting of 41.5% by weight of the polypropylene of (4), 53.5% by weight of the elastomer of (2) and 5% by weight of the high-density polyethylene of (3).

C-3 :上記(4) のポリプロピレン 3 0重量%、 上記(2) のエラス トマ一 6 5重 量%および上記( 3 ) の高密度ポリエチレン 5重量%からなる混合樹脂 C-3: A mixed resin comprising 30% by weight of the polypropylene of (4), 65% by weight of the elastomer of (2) and 5% by weight of the high-density polyethylene of (3).

C-4 :上記(4) のポリプロピレン 45重量%、 上記(2) のエラストマ一 45重 量%および上記(3) の高密度ポリエチレン 1 0重量%からなる混合樹脂  C-4: Mixed resin consisting of 45% by weight of polypropylene of (4), 45% by weight of elastomer of (2) and 10% by weight of high-density polyethylene of (3)

〔前記 (D) の混合樹脂〕  (Mixed resin of (D))

D-1 :上記(4) のポリプロピレン 45重量%および上記(2) のエラストマ一 5 5重量%からなる混合樹脂  D-1: Mixed resin consisting of 45% by weight of polypropylene of (4) and 55% by weight of elastomer of (2)

実施例 1〜5、 比較例 1〜4  Examples 1 to 5, Comparative Examples 1 to 4

(多層フィルムの製造)  (Manufacture of multilayer film)

上記 A- 1 , B-1 , C- 1 〜C-4および D- 1の樹脂 (混合樹脂) を用いて、 下記の表 1に示す層構成のフィルムを、水冷共押出しインフレーション法により成形した。 なお、 比較例 2の多層フィルムは、 第 3層に相当する層を有しない 4層フィル W Using the above resins A-1, B-1, C-1 to C-4 and D-1 (mixed resin), films with the layer composition shown in Table 1 below were formed by water-cooled coextrusion inflation. . The multilayer film of Comparative Example 2 was a four-layer film having no layer corresponding to the third layer. W

12  12

ムであった。 Was

また、 中間層である第 2および第 4層に用いられている混合樹脂(C)の組成が 本発明の範囲から外れている比較例 4は、 成形が困難でフィルムを得ることがで きなかった。  In Comparative Example 4 in which the composition of the mixed resin (C) used in the second and fourth layers as the intermediate layers was out of the range of the present invention, molding was difficult and a film could not be obtained. Was.

[表 1]  [table 1]

上 ■ HE iの里類、 卜 · 厚み Above ■ HE i villages

H 3 ® 第 4層 第 5層 H 3 ® 4th layer 5th layer

A-1 B-l A-1 C-l A-1 実施例 1 20 πι 100 m 10/ m 100 m 30 m  A-1 B-l A-1 C-l A-1 Example 1 20 πι 100 m 10 / m 100 m 30 m

A-1 C-l A-1 C-l A-1 実施例 2 20^m 100 Aim 10/ m lOO^m 30 Am  A-1 C-l A-1 C-l A-1 Example 2 20 ^ m 100 Aim 10 / m lOO ^ m 30 Am

A-1 B-l D-l C-l A-1 実施例 3 20 πι 95 m 20 m 95 m 30 Mm  A-1 B-l D-l C-l A-1 Example 3 20 πι 95 m 20 m 95 m 30 Mm

A-1 C-2 A-1 C-2 A-1 実施例 4 20 m 100 Am ΙΟ ιη 100 m 30 ιη  A-1 C-2 A-1 C-2 A-1 Example 4 20 m 100 Am ΙΟ ιη 100 m 30 ιη

A-1 C-l D-l C-l A-1 実施例 5 20 m 95 ιη 20 Mm 95 μ m 30 im  A-1 C-l D-l C-l A-1 Example 5 20 m 95 ιη 20 Mm 95 μm 30 im

A-1 D-l A-1 D-l A-1 比較例 1 20 πι 100 m 10/ m 100 μ m 30 ιη  A-1 D-l A-1 D-l A-1 Comparative Example 1 20 πι 100 m 10 / m 100 μm 30 ιη

A-1 B-l C-l A-1 比較例 2 30 im 100 Mm 100 ηι 30 ηι A-1 B-l C-l A-1 Comparative Example 2 30 im 100 Mm 100 ηι 30 ηι

A-1 C-3 A-1 C-3 A-1 比較例 3 20 m 100 μιη 10 m 100 ιη 30 π A-1 C-3 A-1 C-3 A-1 Comparative example 3 20 m 100 μιη 10 m 100 ιη 30 π

A-1 C-4 D-l C-4 A-1 比較例 4 20 ιη 95μιη 20 Aim 95 μ m 30 Mm  A-1 C-4 D-l C-4 A-1 Comparative Example 4 20 ιη 95μιη 20 Aim 95 μm 30 Mm

(容器の製造) (Manufacture of containers)

次に、 上記実施例 1〜5、 比較例 1〜4のフィルムを用いて、 図 1に示すよう な内容量 50 Omlの医療用容器 (輸液バッグ) 10を製造した。 この医療用容 器 10を成形する際の周縁部のヒートシールは 155°Cで 4. 5秒間行い、 口部 材 20のシールは 140~ 150°Cで 3秒間行った。  Next, using the films of Examples 1 to 5 and Comparative Examples 1 to 4, a medical container (infusion bag) 10 having a content of 50 Oml as shown in FIG. 1 was produced. When molding the medical container 10, heat sealing of the peripheral portion was performed at 155 ° C for 4.5 seconds, and sealing of the mouth member 20 was performed at 140 to 150 ° C for 3 seconds.

(性能試験)  (performance test)

試験例 1  Test example 1

上記実施例 1〜 5の多層フィルムを用いて得られた医療用容器 (輸液バッグ) 10について、 各種特性の評価試験を以下の方法により行った。 •耐熱性:容器に蒸留水を充填し、 1 1 0 °C、 4 0分間の高圧蒸気滅菌処理を した後、 その容器の変形、 破袋、 シール漏れの状態を目視で観察した。 With respect to the medical container (infusion bag) 10 obtained using the multilayer films of Examples 1 to 5, evaluation tests of various characteristics were performed by the following methods. • Heat resistance: The container was filled with distilled water and subjected to high-pressure steam sterilization at 110 ° C for 40 minutes, and the container was visually inspected for deformation, bag breakage, and seal leakage.

•落下試験:約 4 °Cに冷蔵した後、 容器を 3方向から各 5回ずつ、 l mの高さ から落下させた後、 破袋およびシール漏れの状態を目視で観察した。  • Drop test: After refrigerated at about 4 ° C, the containers were dropped five times each from three directions from a height of 1 m, and the state of bag breakage and seal leakage was visually observed.

•柔軟性:内溶液の自然排出性を目視で観察した。  • Flexibility: Spontaneous discharge of the internal solution was visually observed.

•透明性:容器に蒸留水を充填し、 前述と同様にして高圧蒸気滅菌処理を施し た後、 目視で観察し、 さらに 4 5 O n mの光透過率を測定した。  • Transparency: A container was filled with distilled water, subjected to high-pressure steam sterilization in the same manner as described above, visually observed, and further measured at a light transmittance of 45 Onm.

'外観: 目視で観察し、 しわ、 ブロッキング、 変形および破袋の状況を調べた。 上記耐熱性、 落下試験、 柔軟性、 透明性および外観の評価において、 ◎は非常 に良好、 〇は良好 (実用に適している) 、 △はやや不良 (実用上不適当) 、 Xは 不良を示す。  'Appearance: Observed visually to check for wrinkles, blocking, deformation and breakage. In the above heat resistance, drop test, flexibility, transparency and appearance evaluation, ◎ indicates very good, 〇 indicates good (suitable for practical use), Δ indicates slightly poor (practically inappropriate), and X indicates bad. Show.

以上の試験結果を表 2に示す。  Table 2 shows the test results.

[表 2 ] 実施例 1 実施例 2 実施例 3 実施例 4 実施例 5 耐 熱 性 ◎ ◎ ◎ ◎ ◎ [Table 2] Example 1 Example 2 Example 3 Example 4 Example 5 Heat resistance ◎ ◎ ◎ ◎ ◎

落下試験 ◎ ◎ ◎ ◎ ◎  Drop test ◎ ◎ ◎ ◎ ◎

柔 軟 性 ◎ ◎ ◎ ◎  Flexible ◎ ◎ ◎ ◎

透 明 性  transparency

目 視 ◎ ◎ ◎ ◎ ◎  Visual ◎ ◎ ◎ ◎ ◎

透過率% 83.2 83.4 85.3 85.7 88.0 外 観 ◎ ◎ ◎ ◎ ◎  Transmittance% 83.2 83.4 85.3 85.7 88.0 Appearance ◎ ◎ ◎ ◎ ◎

表 2の結果より明らかなように、 本発明の容器は、 耐熱性、 落下試験、 柔軟性、 透明性および外観のいずれの項目についても非常に良好な結果が得られた。 As is clear from the results in Table 2, the container of the present invention obtained very good results in all of the items of heat resistance, drop test, flexibility, transparency and appearance.

試験例 2  Test example 2

上記実施例 1 ~ 5および比較例 1 ~ 3の多層フィルムを用いて得られた医療用 容器 (輸液バッグ) 1 0に生理食塩液を充填して、 ゴム栓で密閉し、 1 1 0 °C 4 0分間の高圧蒸気滅菌処理を施した。 処理後、 簡易型静電容量式ビンホールテス 夕一〔電測精ェ (株) 製のビンホールテス夕一 H型〕 を用いて、 ピンホールの有 無を検査した。 A medical container (infusion bag) 10 obtained using the multilayer films of Examples 1 to 5 and Comparative Examples 1 to 3 was filled with a physiological saline solution, sealed with a rubber stopper, and kept at 110 ° C. The autoclave was subjected to high-pressure steam sterilization for 40 minutes. After processing, use a simple capacitance type binhole test Yuichi [Dinseisei Co., Ltd. binhole test Yuichi H type] to obtain a pinhole. Nothing was inspected.

検査は、 ロ部材 2 0のシールを 1 4 0 ° (、 1 4 5 °Cおよび 1 5 0 °Cの 3つの条 件で行った容器について、 それそれ荷電圧 1 5 k V、 2 0 1^ ¥ぉょび2 5 ¾: ¥の 3つの条件で各 1 0袋ずつ行った。 すなわち、 合計 9 0袋について検査した。 なお、 上記試験は、 医療用容器の通常の製造条件に比べて極めて過酷な条件で ある。 従って、 かかる条件においてビンホールが発生した検体の割合が 5 %未満 ( 9 0個の検体中 5個未満) であれば、 耐ビンホール性が良好であるとした。 表 3に、 ビンホールが検出された検体数とその割合 (。 ) を示す。  Inspection was conducted on containers that were sealed under the three conditions of 140 ° (, 150 ° C and 150 ° C), respectively. ^ \\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\ Undere _ _ Therefore, if the ratio of samples in which binholes occurred was less than 5% (less than 5 out of 90 samples) under these conditions, it was determined that the binhole resistance was good. Shows the number of samples in which binholes were detected and the ratio (.).

[表 3 ] 実 施 例 比 較 例 [Table 3] Example Comparative example

1 2 3 4 5 1 2 3 検 体 数 4 1 3 4 0 9 15 割合 (%) 4.4 1.1 4.4 3.3 4.4 0 10.0 16.7 表 3より明らかなように、 実施例 1〜 5の容器はいずれもピンホールの発生検 体の割合が 5 %未満であり、 耐ビンホール性が良好であった。  1 2 3 4 5 1 2 3 Number of specimens 4 1 3 4 0 9 15 Ratio (%) 4.4 1.1 4.4 3.3 4.4 0 10.0 16.7 As is clear from Table 3, the containers of Examples 1 to 5 were all pinholes. The proportion of specimens in which pitting occurred was less than 5%, and the binhole resistance was good.

これに対し、 4層の多層フィルムである比較例 2と、 中間層である第 2層およ び第 4層に用いられている混合樹脂(C) の組成が本発明の範囲から外れている比 較例 3とでは、 ピンホールの発生検体の割合が大きく、 耐ビンホール性が実用上 十分ではなかった。  On the other hand, the composition of Comparative Example 2 which is a four-layer multilayer film and the mixed resin (C) used for the second and fourth layers which are the intermediate layers are out of the scope of the present invention. Compared with Comparative Example 3, the proportion of specimens with pinholes was large, and the binhole resistance was not practically sufficient.

なお、 中間層である第 2層および第 4層に用いられている混合樹脂がいずれも 高密度ポリエチレンを含まない比較例 1では、 ピンホールの発生検体の割合が 0 %であって、 耐ピンホール性が極めて優れていた。 しかしながら、 滅菌処理後 に多数のしわが確認されるなど、 外観が極めて不十分で医療用容器としては不適 切であった。  In Comparative Example 1 in which the mixed resin used in the second and fourth layers, which are the intermediate layers, did not contain high-density polyethylene, the proportion of specimens with pinholes was 0%, The hole property was extremely excellent. However, the appearance was extremely inadequate, with many wrinkles observed after sterilization, making it unsuitable as a medical container.

本発明においては、 さらに実施例 1〜5と同様にして、 下記の表 4に示す層構 成のフィルムを成形することができる。 これらのフィルムも、 上記と同様の優れ た性質を有する。 [表 4] 上段:榭脂の種類, 下段:厚み In the present invention, a film having a layer structure shown in Table 4 below can be formed in the same manner as in Examples 1 to 5. These films also have the same excellent properties as described above. [Table 4] Upper: resin type, lower: thickness

1眉 弟 <3層 第 4層 第 5暦 1 eyebrows Brother <3rd layer 4th layer 5th calendar

Ά·1 A-l し- 2 A-l 実施例 6 20μπι 100 ιη 10 im 100 μπι 30 m 11 A-l- 2 A-l Example 6 20μπι 100 ιη 10 im 100 μπι 30 m

A-l B-l D-l C-2 A-l 実施例 7 20 μπι 100 μιη 10 m 100 μιη 30Atm  A-l B-l D-l C-2 A-l Example 7 20 μπι 100 μιη 10 m 100 μιη 30Atm

A-l C-l A-l C-2 A-l 実施例 8 20 ηι 100 μπι ΙΟμπι 100 μπι 30 Mm  A-l C-l A-l C-2 A-l Example 8 20 ηι 100 μπι ΙΟμπι 100 μπι 30 Mm

A-l C-l D-l C-2 A-l 実施例 9 A-l C-l D-l C-2 A-l Example 9

Figure imgf000017_0001
Figure imgf000017_0001

実施例 10 20 μιη 100 πι 10 μιη 100 πι 30um  Example 10 20 μιη 100 πι 10 μιη 100 πι 30um

A-l C-2 D-l C-l A-l 実施例 11 20 ηι 100 Mm ΙΟμηι 100 Mm 30 im  A-l C-2 D-l C-l A-l Example 11 20 ηι 100 Mm ΙΟμηι 100 Mm 30 im

A-l C-2 D-l C-2 A-l 実施例 12 20 πι 100 πι ΙΟ ιη 100 im 30 m  A-l C-2 D-l C-2 A-l Example 12 20 πι 100 πι ΙΟ ιη 100 im 30 m

産業上の利用可能性 本発明による多層フィルムおよび容器は、 耐熱性、 耐ブロッキング性、 強度、 シール性、 透明性、 柔軟性および外観が優れているとともに、 さらにヒートシ一 ル時に屈曲部等でビンホールが発生しないといった利点を有し、 輸液バッグ、 血 液バッグなどの医療用容器として好適に用いることができる。 INDUSTRIAL APPLICABILITY The multilayer film and the container according to the present invention are excellent in heat resistance, blocking resistance, strength, sealability, transparency, flexibility and appearance, and furthermore have a binhole at a bent portion or the like during heat sealing. It has the advantage that no blood is generated, and can be suitably used as medical containers such as infusion bags and blood bags.

Claims

請求の範囲 The scope of the claims 1. 5層からなる多層フィルムであって、 1. a multilayer film consisting of five layers, 第 1層および第 5層が(A)密度 0. 930〜0. 950 g/ cm3のエチレン ' ひ一才レフィン共重合体であり、 The first layer and the fifth layer are (A) an ethylene′-one-strength olefin copolymer having a density of 0.930 to 0.950 g / cm 3 , 5 第 2層が  5 The second layer (B)密度 0. 9 10〜0. 930 g/cm3のエチレン ' ひ一ォレフィン共重合体 30~ 60重量%、 密度 0. 860〜0. 900 g/cm3のエチレン · α—ォレ フィン系エラストマ一 35〜65重量%および密度 0. 955〜0. 970 g/ cm3の高密度ポリエチレン 1〜 10重量%からなる混合樹脂、 または (B) Density 0. 9 10~0. 930 g / cm 3 of ethylene 'shed one Orefin copolymer 30-60 wt%, a density from 0.860 to 0. Of 900 g / cm 3 ethylene · alpha-O les fin elastomers one 35-65 wt% and density 0. 955~0. 970 g / cm 3 density polyethylene 1 mixed resin consisting of 10 wt% or, 10 (C)密度 0. 900〜0. 930 g/cm3のポリプロピレン 35〜55重量%、 密度 0. 860〜0. 900 g/cm3のエチレン · α—ォレフィン系エラストマ 一 40〜60重量%および密度 0. 955〜0. 970 g/ c m3の高密度ポリエ チレン 2〜 8重量%からなる混合樹脂であり、 10 (C) Density 0.95 to 0.930 g / cm 3 polypropylene 35 to 55% by weight, Density 0.860 to 0.900 g / cm 3 ethylene / α-olefin elastomer 40 to 60% by weight and density from 0.955 to 0. a 970 mixed resin consisting of high density polyethylene having 2-8 wt% of g / cm 3, 第 3層が  The third tier 15 前記 (A) のエチレン ' ひ一才レフイン共重合体、 または  15 The ethylene'-one-year-old olefin copolymer of the above (A), or (D)密度 0. 900〜0. 930 g/cm3のポリプロピレン 40~ 60重量%ぉ よび密度 0. 860〜0. 900 g/cm3のエチレン · ひ一ォレフィン系エラス トマ一 40~60重量%からなる混合樹脂であり、 かつ (D) Density 0. from 900 to 0. 930 g / cm 3 Polypropylene 40-60% by weight per cent and a density from 0.860 to 0.900 ethylene flying one Orefin system Elastica Tomah one 40-60 weight g / cm 3 % Mixed resin, and 第 4層が前記 (C) の混合樹脂  The fourth layer is the mixed resin of the above (C) 20 であることを特徴とする多層フィルム。  20. A multilayer film, which is 20. 2. 第 2層が前記 (C) の混合樹脂であり、 かつ第 3層が前記 (A) のエチレン ' ひ一才レフィン共重合体である請求項 1記載の多層フィルム。 2. The multilayer film according to claim 1, wherein the second layer is the mixed resin of (C), and the third layer is the ethylene′-one-strand olefin copolymer of (A). E5 3. 前記ポリプロピレンが、 そのメルトフ口一レート (MFR) が 1〜40 g /10分 ( 230°C) 、 融点が 140〜 170°Cのアイソタクティックポリプロ ピレンである請求項 1または 2記載の多層フィルム。 E5 3. The polypropylene according to claim 1 or 2, wherein the polypropylene is an isotactic polypropylene having a melt flow rate (MFR) of 1 to 40 g / 10 minutes (230 ° C) and a melting point of 140 to 170 ° C. Multilayer film. 4. 各層の厚みの割合が、 フィルム全体の厚みに対して、 4. The ratio of the thickness of each layer is 第 1層: 5〜 15%、 First tier: 5-15%, 第 2層: 25〜 45%、 Tier 2: 25-45%, 第 3層: 2〜15%、 Third tier: 2-15%, 第 4層: 25〜45%、 Fourth layer: 25-45%, 第 5層: 7〜20% Fifth layer: 7-20% の範囲にある請求項 1 ~ 3のいずれかに記載の多層フィルム。 The multilayer film according to any one of claims 1 to 3, wherein 5. 各層の厚みの割合が、 フィルム全体の厚みに対して、 5. The ratio of the thickness of each layer is 第 1層: 5〜: L 0%、 First layer: 5 ~: L 0%, 第 2層: 30〜45 %、 Second layer: 30-45%, 第 3層: 2〜10%、 Third layer: 2-10%, 第 4層: 30-45 %、 Tier 4: 30-45%, 第 5層: 7〜: L 5% Fifth layer: 7 ~: L 5% の範囲にある請求項 4記載の多層フィルム。 5. The multilayer film according to claim 4, wherein 6. フィルム全体の厚みが 200-300 /mである請求項 4または 5記載の 多層フィルム。 6. The multilayer film according to claim 4, wherein the thickness of the entire film is 200 to 300 / m. 7. 請求項 1〜 6のいずれかに記載の多層フィルムを用い、 この多層フィルム の第 1層を外層とし、 第 5層を内層として成形されたことを特徴とする容器。 7. A container formed by using the multilayer film according to any one of claims 1 to 6, wherein the first layer of the multilayer film is an outer layer and the fifth layer is an inner layer. 8. ポリエチレン製口部材をフィルムの間に挟んで溶着してなる請求項 7記載 の容器。 8. The container according to claim 7, wherein a polyethylene mouth member is welded sandwiched between the films.
PCT/JP1999/006932 1998-12-14 1999-12-09 Multilayered film and container Ceased WO2000035673A1 (en)

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